Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients

University of Barcelona

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Chronic Periodontitis

Treatments: Procedure: Nonsurgical periodontal treatment; Procedure: Dental Prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT02652026

UBarcelona

Details and patient eligibility

About

The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group, Control Group.

Full description

Background: Periodontitis and diabetes are both highly prevalent conditions, and the association between these two common diseases has been recognised by dental professionals for many years.

Aim: The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM).

Methods: This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group (TG) (Oral Hygiene Instructions (OHI) + scaling and root planing (RAR) using ultrasound device and Gracey curettes); Control Group (CG) (OHI + supragingival removal of plaque and calculus with ultrasonic device). CG patients receive salvage therapy if a significant worsening of their periodontal status and / or metabolic observed. Periodontal assesment (probing pocket depth (PPD), gingival index (GI), and plaque index (PI)) and systemic assesment (random blood sugar, glycosylated hemoglobin (HbA1C), and salivary cytokines) and bacterial asessment at baseline and 3, 6 months after treatment is performed. There will be a single examiner, blind and calibrated to improve reproducibility. The investigators' hypothesis is that non-surgical periodontal treatment reduces HbA1c, improving metabolic control in patients with DM

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria were:

• Diagnostic of T2DM (diagnosed at least 1'5 years prior the study).
• Presence of generalized chronic periodontitis (With at least 9 teeth present and more than 30% of locations with probing depth (PD) and clinical attachment level (CAL) ≥4mm).

Exclusion criteria included:

• Patients who received antibiotics the last 15 days, or for a period longer than 10 days the last three months.
• Having received non-surgical periodontal treatment within the past 6 months.
• Pregnancy
• Significant change of medication for diabetes during the course of the study
• Evidence of other serious systemic disease (ASA III or IV) which may influence periodontal disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Treatment Group

Experimental group

Description:

The Treatment Group (TG) received full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron, Acteon, Merignac, France) and Gracey curettes (Hu- Friedy, Chicago, USA).Also received Oral Hygienic Instructions

Treatment:

Procedure: Dental Prophylaxis

Procedure: Nonsurgical periodontal treatment

Control Group

Active Comparator group

Description:

The Control Group (CG) received periodontal prophylaxis at baseline, by removal of supragingival deposits (plaque and calculus) with ultrasonic scaler. Also received Oral Hygienic Instructions

Treatment:

Procedure: Dental Prophylaxis